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510(k) Data Aggregation

    K Number
    K970240
    Device Name
    DIFFUSER PANEL
    Date Cleared
    1997-03-11

    (48 days)

    Product Code
    Regulation Number
    892.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOCUSED VIEWER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Diffuser Panel is designed to diffuse the light source in Radiographic Film Illuminators.
    Device Description
    The Diffuser Panel consists of layers of light diffusing and brightness enhancer films, plus a clear polycarbonate panel that is coated with a scratch guard to protect the surface of the brightness enhancer from scratching.
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